GMP Good manufacturing practice and regulatory affairs for bioengineers

1 Credit

Review of the principles of the Food and Drug Administration including its history, mission and applied regulations. Understanding of how the FDA works with industry and is integral to the development of new products and technologies. Review and critique of case studies in various parts of the biomedical industry to see how FDA regulations are applied. Validation and analysis of products using failure mode analysis. Students in the class must have at least junior standing. Prerequisites: BIOE 110 Can be taken Concurrently: BIOE 110